AzTrials
AzTrials

Pulmonary Disease, Chronic ObstructivePhase 3NCT01772134

Efficacy and Safety of the Addition of Fluticanse Propionate/Salmeterol (250/50mcg) Twice-daily to 2 Doses of Umeclidinium Bromide (62.5 or 125mcg) Once-daily Over 12 Weeks

A Phase 3 study testing Umeclidinium bromide 62.5mcg, Umeclidinium bromide 125mcg and Fluticasone propionate 250mcg/Salmeterol 50mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 73 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this 12 week study is to evaluate the effects of the addition of umeclidinium bromide (62.5mcg) once-daily to fluticanse propionate/salmeterol (250/50mcg) twice-daily, umeclidinium bromide (125mcg) once-daily to fluticanse propionate/salmeterol (250/50mcg) twice-daily versus placebo to fluticanse… Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
Umeclidinium bromide 62.5mcg, Umeclidinium bromide 125mcg and Fluticasone propionate 250mcg/Salmeterol 50mcg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
617 participants
Where
73 sitesin 4 countries
Study dates
1 Jan 2013to 22 Jul 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • -Type of subject: Outpatient.
  • Informed Consent: A signed and dated written informed consent prior to study participation.
  • Age: Subjects 40 years of age or older at Visit 1.
  • Gender: Male or female subjects. A female is eligible to enter and participate if of non-childbearing potential, or if of child bearing potential, has a negative serum pregnancy test at screening, and agrees to one of the acceptable contraceptive methods listed in the protocol, used consistenty and correctly.
  • Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society.
  • Smoking History: Current or former cigarette smokers with a history of cigarette smoking of ≥10 pack-years [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Pipe and/or cigar use cannot be used to calculate pack year history.
  • Severity of Disease: A pre and post-albuterol/salbutamol FEV1/FVC ratio of <0.70 and a pre and post-albuterol/salbutamol FEV1 of ≤70% of predicted normal values at Visit 1 (Screening) calculated using Nutrition Health and Examination Survey (NHANES) III reference equations.
  • Dyspnea: A score of ≥2 on the mMRC Dyspnea Scale at Visit 1.

Who cannot join

  • Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
  • Asthma: A current diagnosis of asthma.
  • Other Respiratory Disorders: Known α-1 antitrypsin deficiency, active lung infections (such as tuberculosis), and lung cancer are absolute exclusionary conditions. A subject who, in the opinion of the investigator, has any other significant respiratory conditions in addition to COPD should be excluded. Examples may include clinically significant bronchiectasis, pulmonary hypertension, sarcoidosis, or interstitial lung disease.
  • Other Diseases/Abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled and/or a previous history of cancer in remission for <5 years prior to Visit 1 (localized carcinoma of the skin that has been resected for cure is not exclusionary). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
  • Contraindications: Any history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, beta2-agonist, sympathomimetic, corticosteroid (intranasal, inhaled or systemic) lactose/milk protein or magnesium stearate, or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the study physician contraindicates study participation or use of an inhaled anticholingeric.
  • Hospitalization: Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1.
Show all 17Show fewer
  • Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior to Visit 1.
  • 12-Lead ECG: An abnormal and significant ECG finding from the 12-lead ECG conducted at Visit 1. Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility.
  • Specific ECG findings that preclude subject eligibility are listed in Appendix 4. The study investigator will determine the medical significance of any ECG abnormalities not listed in Appendix 4.
  • Medication Prior to Spirometry: Unable to withhold albuterol/salbutamol for the 4 hour period required prior to spirometry testing at each study visit.
  • Medications Prior to Screening: Use of the medications listed in the protocol according to protocol-specific times prio to visit 1.
  • Oxygen: Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed for greater than 12 hours a day. As-needed oxygen use (i.e., ≤12 hours per day) is not exclusionary.
  • Nebulized Therapy: Regular use (prescribed for use every day, not for as-needed use) of short-acting bronchodilators (e.g., albuterol/salbutamol) via nebulized therapy.
  • Pulmonary Rehabilitation Program: Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded.
  • Drug or Alcohol Abuse: A known or suspected history of alcohol or drug abuse within 2 years prior to Visit 1.
  • Affiliation with Investigator Site: A subject will not be eligible for this study if he/she is an immediate family member of the participating investigator, subinvestigator, study coordinator, or employee of the participating investigator.
  • Inability to read: In the opinion of the investigator, any subject who is unable to read and/or would not be able to complete a questionnaire.

Trial locations and contacts

73 sites in 4 countries.

73 sites in 4 countries

Germany35 sites

  • GSK Investigational Site

    Bamberg, Bavaria, 96049

  • GSK Investigational Site

    Berlin, 13125

  • GSK Investigational Site

    Berlin, 13156

  • GSK Investigational Site

    Berlin, 14059

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 51069

  • GSK Investigational Site

    Dresden, Saxony, 01069

  • GSK Investigational Site

    Düren, North Rhine-Westphalia, 52349

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45355

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45359

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60389

  • GSK Investigational Site

    Gelnhausen, Hesse, 63571

  • GSK Investigational Site

    Gera, Thuringia, 07548

  • GSK Investigational Site

    Goch, North Rhine-Westphalia, 47574

  • GSK Investigational Site

    Hamburg, 22143

  • GSK Investigational Site

    Hamburg, 22299

  • GSK Investigational Site

    Hamburg, 22767

  • GSK Investigational Site

    Hanover, Lower Saxony, 30159

  • GSK Investigational Site

    Hanover, Lower Saxony, 30173

  • GSK Investigational Site

    Kassel, Hesse, 34121

  • GSK Investigational Site

    Koblenz, Rhineland-Palatinate, 56068

  • GSK Investigational Site

    Leipzg, Saxony, 04109

  • GSK Investigational Site

    Leipzig, Saxony, 04103

  • GSK Investigational Site

    Leipzig, Saxony, 04207

  • GSK Investigational Site

    Leipzig, Saxony, 04357

  • GSK Investigational Site

    Lübeck, Schleswig-Holstein, 23552

  • GSK Investigational Site

    Magdeburg, Saxony-Anhalt, 39112

  • GSK Investigational Site

    Reinfeld, Schleswig-Holstein, 23858

  • GSK Investigational Site

    Schmölln, Thuringia, 04626

  • GSK Investigational Site

    Schwabach, Bavaria, 91126

  • GSK Investigational Site

    Schwerin, Mecklenburg-Vorpommern, 19055

  • GSK Investigational Site

    Sinsheim, Baden-Wurttemberg, 74889

  • GSK Investigational Site

    Stuttgart, Baden-Wurttemberg, 70378

  • GSK Investigational Site

    Teuchern, Saxony-Anhalt, 6682

  • GSK Investigational Site

    Weyhe-Leeste, Lower Saxony, 28844

  • GSK Investigational Site

    Witten, North Rhine-Westphalia, 58452

Other trials in Germany

Canada17 sites

  • GSK Investigational Site

    Bay Roberts, Newfoundland and Labrador, A0A 1G0

  • GSK Investigational Site

    Burlington, Ontario, L7N 3V2

  • GSK Investigational Site

    Gatineau, Quebec, J8Y 6S8

  • GSK Investigational Site

    Greater Sudbury, Ontario, P3E 1H5

  • GSK Investigational Site

    Mirabel, Quebec, J7J 2K8

  • GSK Investigational Site

    Montreal, Quebec, H2R 1V6

  • GSK Investigational Site

    Québec, Quebec, G1V 4G5

  • GSK Investigational Site

    Québec, Quebec, G3K 2P8

  • GSK Investigational Site

    Saint Romuald, Quebec, G6W 5M6

  • GSK Investigational Site

    Saint-Charles-Borromée, Quebec, J6E 2B4

  • GSK Investigational Site

    Sarnia, Ontario, N7T 4X3

  • GSK Investigational Site

    Toronto, Ontario, M5G 1N8

  • GSK Investigational Site

    Toronto, Ontario, M9W 4L6

  • GSK Investigational Site

    Trois-Rivières, Quebec, G8T 7A1

  • GSK Investigational Site

    Truro, Nova Scotia, B2N 1L2

  • GSK Investigational Site

    Vancouver, British Columbia, V6J 1S3

  • GSK Investigational Site

    Winnipeg, Manitoba, R2K 3S8

Other trials in Canada

United States13 sites

  • GSK Investigational Site

    Clearwater, Florida, 33765

  • GSK Investigational Site

    Easley, South Carolina, 29640

  • GSK Investigational Site

    Edina, Minnesota, 55435

  • GSK Investigational Site

    Greenville, South Carolina, 29615

  • GSK Investigational Site

    Jasper, Alabama, 35501

  • GSK Investigational Site

    Lafayette, Indiana, 47904

  • GSK Investigational Site

    Medford, Oregon, 97504

  • GSK Investigational Site

    Morgantown, West Virginia, 26505

  • GSK Investigational Site

    New Orleans, Louisiana, 70115

  • GSK Investigational Site

    Ormond Beach, Florida, 32174

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    Union, South Carolina, 29379

Other trials in United States

South Korea8 sites

  • GSK Investigational Site

    Bucheon-si, 420-767

  • GSK Investigational Site

    Cheongju, Chungcheongbuk-do, 361-711

  • GSK Investigational Site

    Kangwon-do, 220-701

  • GSK Investigational Site

    Seoul, 130-872

  • GSK Investigational Site

    Seoul, 136-705

  • GSK Investigational Site

    Seoul, 137-701

  • GSK Investigational Site

    Seoul, 156-707

  • GSK Investigational Site

    Suwon, Gyeonggi-do, 442-723

Other trials in South Korea

About this study

Official title: A Multicenter, Randomized, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of the Addition of Umeclidinium Bromide (62.5mcg) Once-daily to Fluticasone Propionate/Salmeterol (250/50mcg) Twice-daily, Umeclidinium Bromide (125mcg) Once-daily to Fluticasone Propionate/Salmeterol (250/50mcg) Twice-daily Versus Placebo to Fluticasone Propionate/Salmeterol (250/50mcg) Twice-daily Over 12 Weeks With COPD

The purpose of this 12 week study is to evaluate the effects of the addition of umeclidinium bromide (62.5mcg) once-daily to fluticanse propionate/salmeterol (250/50mcg) twice-daily, umeclidinium bromide (125mcg) once-daily to fluticanse propionate/salmeterol (250/50mcg) twice-daily versus placebo to fluticanse propionate/salmeterol (250/50mcg) twice-daily on lung function, COPD-related health status assessments and safety in COPD subjects.

Read the detailed description

This is a mutlicenter, randomized, double-blind, parallell-group study. Subejcts who meet the eligibility criteria at screening and meet the randomization criteria at the end of a 4 week run-in period will enter a 12 week treatment period. There will be a 7 day follow-up period after the treatment period.

Being tested
Umeclidinium bromide 62.5mcg, Umeclidinium bromide 125mcg, Fluticasone propionate 250mcg/Salmeterol 50mcg, Placebo
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Umeclidinium bromide 62.5mcgDrug

    Inhalation Powder, LAMA 62.5mcg

  • Umeclidinium bromide 125mcgDrug

    Inhalation Powder, LAMA 125mcg

  • Fluticasone propionate 250mcg/Salmeterol 50mcgDrug

    Inhalation Powder, ICS/LABA

  • PlaceboDrug

    Inhalation Powder, Placebo

Study groups in NCT01772134
Study groupRoleWhat they receive
Umeclidinium bromide 62.5 + Fluticasone propionate/SalmeterolExperimentalLong-acting muscarinic antagonist (LAMA), 62.5mcg plus Inhaled corticosteriod (ICS), 250mcg/ Long acting Beta agonist (LABA), 50mcg
Receives: Drug: Umeclidinium bromide 62.5mcg; Drug: Fluticasone propionate 250mcg/Salmeterol 50mcg
Umeclidinium bromide 125 + Fluticasone propionate/SalmeterolActive comparatorLong-acting muscarinic antagonist (LAMA), 125mcg plus Inhaled corticosteriod (ICS), 250mcg/ Long acting Beta agonist (LABA), 50mcg
Receives: Drug: Umeclidinium bromide 125mcg; Drug: Fluticasone propionate 250mcg/Salmeterol 50mcg
Placebo + Fluticasone propionate/SalmeterolPlacebo comparatorInhaled corticosteriod (ICS), 250mcg/ Long acting Beta agonist (LABA), 50mcg
Receives: Drug: Fluticasone propionate 250mcg/Salmeterol 50mcg; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in the Trough Forced Expiratory Volume in One Second (FEV1) on Day 85

    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Treatment Day 84 (i.e., at Week 12). Baseline trough FEV1 is the mean of the two assessments made at -30 and -5 minutes (min) pre-dose on Treatment Day 1. Change from Baseline was calculated as the Day 85 value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made at -30 and -5 min pre-dose on Treatment Day 1), smoking status, day, day by Baseline and day by treatment interactions.

    Measured: Baseline and Day 85

Secondary outcomes (3)

  1. Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 84

    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean FEV1 was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. The weighted mean was calculated using the 24-hour serial FEV1 measurements at Day 84, which included pre-dose, and post-dose at 15 min, 30 min, 1 hour, 3 hours, and 6 hours. Baseline trough FEV1 is the mean of the two assessments made at -30 and -5 min pre-dose on Treatment Day 1. Change from Baseline was calculated as the Day 84 value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made at -30and -5 min pre-dose on Treatment Day 1), smoking status, day, day by Baseline and day by treatment interactions.

    Measured: Baseline and Day 84

  2. Change From Baseline in the Mean Percentage of Rescue-free Days Over Weeks 1-12

    A rescue-free day is defined as a day on which no rescue medication was taken. Baseline calculations include a period of the later of 27 days before Visit 2 and the day after Visit 1, up to and including Day 1. The Weeks 1-12 calculations include a period from Study Day 2 up to the earlier of Study Day 85 and the day before Visit 7. Change from Baseline was calculated as the Weeks 1-12 value minus the Baseline value.

    Measured: Baseline and Weeks 1-12

  3. Change From Baseline in the Mean Number of Puffs Per Day of Rescue Albuterol/Salbutamol Over Weeks 1-12

    The mean number of puffs per day of rescue albuterol/salbutamol at Baseline and on-treatment was recorded. The total puffs of rescue albuterol/salbutamol for each day was calculated as: (number of puffs + [2 * number of nebules]). Baseline calculations include a period of the later of 27 days before Visit 2 and the day after Visit 1, up to and including Day 1. The Weeks 1-12 calculations include a period from Study Day 2 up to the earlier of Study Day 85 and the day before Visit 7. Change from Baseline was calculated as the Weeks 1-12 value value minus the Baseline value. Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of treatment, Baseline (mean during the 4 weeks prior to Day 1), and smoking status.

    Measured: Baseline and Weeks 1-12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2013 (estimated)
  2. Study start1 Jan 2013
  3. Primary completion1 Jul 2013
  4. Study completion22 Jul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
617 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01772134
Sponsor's protocol ID
116135
Status last verified
Jan 2018
First submitted
17 Jan 2013
Last updated
29 Jan 2018
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Umeclidinium bromide 62.5mcg, Umeclidinium bromide 125mcg and Fluticasone propionate 250mcg/Salmeterol 50mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 73 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in Germany, Canada, United States, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Trough Forced Expiratory Volume in One Second (FEV1) on Day 85 (time frame: Baseline and Day 85). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01772134.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in